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PRESIDENTIAL DECREE OF THE REPUBLIC OF UZBEKISTAN

of August 19, 2025 No. UP-137

About additional measures for regulation of drug circulation and medical products

(as amended of the Presidential decree of the Republic of Uzbekistan of 05.05.2026 No. UP-77)

For the purpose of providing the population with high-quality, safe medicines and medical products with the guaranteed efficiency, enhancement of processes of regulation of their address, creating favorable conditions for subjects of entrepreneurship, and also acceleration of processes of integration into the World Trade Organization I decide:

I. Purposes

1. Determine main objectives of regulation of drug circulation and medical products:

(a) providing the population with the high-quality, safe and effective medicines and medical products recognized by the World Health Organization and registered in the countries which system of regulation has the high level of maturity;

(b) reduction of order of registration of medicines and medical products in compliance with the international requirements;

(c) regulation of the address in the pharmaceutical market of the Republic of Uzbekistan of the medicines and medical products made on the basis of international standards of quality.

II. Enhancement of order of registration by recognition

2. Establish procedure according to which since October 1, 2025 the medicines registered by the following foreign organizations are subject to state registration in the Republic of Uzbekistan by their recognition:

(a) the regulatory bodies included before entry into force of this Decree in the list of the World Health Organization (WHO Listed Authorities);

(b) the regulatory bodies having 4 level of maturity (Maturity Level 4) on the Global tool of comparative assessment (Global Benchmarking Tool) of the World Health Organization.

III. Enhancement of regulation of drug circulation and medical products

3. Perform since January 1, 2026 the product circulation of medical appointment and medical equipment in the following procedure:

(a) to carry out state registration of products of medical appointment and medical equipment as medical products;

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